A Comparison of Exparel Local Anesthetic in Total Knee Arthroplasty (TKA) Patients
A Prospective Randomized Case Series Comparison on the Clinical Efficacy of Exparel Local Anesthetic in Total Knee Arthroplasty Patients
調査の概要
状態
詳細な説明
This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period. Subjects scheduled for a planned total knee arthroplasty procedure will be consented and those meeting study criteria will be randomized to receive intra-operative injections at the surgical site of liposomal bupivicaine plus a multi-drug cocktail, or a multi-drug cocktail alone.
This study will recruit subjects on an ongoing basis with a minimum of 130 study participants and a maximum of 156. Efficacy data on surgical pain control and safety data will be collected at frequent intervals during the hospitalization. Each study participant will be followed for a minimum 6 week follow-up period.
研究の種類
段階
- フェーズ 4
連絡先と場所
研究場所
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Florida
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Fort Lauderdale、Florida、アメリカ、33334
- Holy Cross Hospital Orthopedic Research Institute
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 18 to 88 years of age.
- Subject is scheduled to undergo primary unilateral Total Knee Arthroplasty.
- Subject willing and able to sign the informed consent.
- Subject is fluent in verbal and written English.
- Subject agrees to take Liposomal bupivacaine or standard of care equivalent.
Exclusion Criteria:
- Previous Partial or Total Knee Arthroplasty of the study knee. Previous Non-Implant surgery on the study knee and contralateral knee is permitted.
- Subject is pregnant or planning to become pregnant while enrolled in the study.
- Subject has a history of narcotic or alcohol abuse.
- Subjects with hepatic disease or renal impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x upper limit of normal or estimated glomerular filtration rate (eGFR) < 30 ml/min within 30 days of surgery).
- For any reason, in the opinion of the investigator, the Subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, etc.)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:Exparel plus multi-drug cocktail
Liposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg.
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他の名前:
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アクティブコンパレータ:Multi-drug cocktail alone
Bupivacaine 0.5% with Epinephrine, Ketorolac 30mg, Morphine 10mg.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Patient reported Visual Analog Scale (VAS) pain intensity score. Post-surgery hours 4-24.
時間枠:VAS pain intensity scores will be collected starting four hours after end of surgery and every 4 hours thereafter until hour 24.
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The area under the curve (AUC) of the VAS scores from 4-24 hours will be compared between the two treatment groups.
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VAS pain intensity scores will be collected starting four hours after end of surgery and every 4 hours thereafter until hour 24.
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Patient reported VAS pain intensity score. Post-surgery hours 24-48.
時間枠:VAS pain intensity scores will be collected starting 24 hours after end of surgery and every 4 hours thereafter until hour 48, or discharge.
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The AUC of the VAS scores from 24-48 hours or until discharge will be compared between the two treatment groups.
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VAS pain intensity scores will be collected starting 24 hours after end of surgery and every 4 hours thereafter until hour 48, or discharge.
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Patient reported VAS pain intensity score. Post-surgery hours 48-72.
時間枠:VAS pain intensity scores will be collected starting 48 hours after end of surgery and every 4 hours thereafter until hour 72, or discharge.
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The AUC of the VAS scores from 48-72 hours or until discharge will be compared between the two treatment groups.
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VAS pain intensity scores will be collected starting 48 hours after end of surgery and every 4 hours thereafter until hour 72, or discharge.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Cost:benefit analysis
時間枠:TKA hospitalization charges, and VAS pain intensity scores pre-operative on day of surgery, 2-week and 6-week followup visits.
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Correlation between hospital charges and improvement in VAS pain intensity score from baseline to the 2-week and 6-week follow-up time points.
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TKA hospitalization charges, and VAS pain intensity scores pre-operative on day of surgery, 2-week and 6-week followup visits.
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協力者と研究者
捜査官
- 主任研究者:Martin Roche, MD、Holy Cross Orthopedic Research Institute
出版物と役立つリンク
一般刊行物
- Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
- Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.
- Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
- Fetherston CM, Ward S. Relationships between post operative pain management and short term functional mobility in total knee arthroplasty patients with a femoral nerve catheter: a preliminary study. J Orthop Surg Res. 2011 Feb 7;6:7. doi: 10.1186/1749-799X-6-7.
- Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4.
- Broome CB, Burnikel B. Novel strategies to improve early outcomes following total knee arthroplasty: a case control study of intra articular injection versus femoral nerve block. Int Orthop. 2014 Oct;38(10):2087-9. doi: 10.1007/s00264-014-2392-0. Epub 2014 Jun 18.
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
- 関節疾患
- 筋骨格疾患
- リウマチ性疾患
- 関節炎
- 変形性関節症
- 変形性関節症、膝
- 薬の生理作用
- アドレナリン作動薬
- 神経伝達物質のエージェント
- 薬理作用の分子機構
- 中枢神経系抑制剤
- 自律神経剤
- 末梢神経系エージェント
- 酵素阻害剤
- 鎮痛剤
- 感覚系エージェント
- 麻酔薬
- 抗炎症剤、非ステロイド
- 鎮痛剤、非麻薬性
- 抗炎症剤
- 抗リウマチ剤
- シクロオキシゲナーゼ阻害剤
- アドレナリンα作動薬
- アドレナリン作動薬
- 鎮痛薬、オピオイド
- 麻薬
- 局所麻酔薬
- 気管支拡張剤
- 抗喘息薬
- 呼吸器系薬剤
- アドレナリン作動性ベータ作動薬
- 交感神経刺激薬
- 血管収縮剤
- 散瞳薬
- ケトロラック
- ブピバカイン
- モルヒネ
- エピネフリン
- ラセピネフリン
- ホウ酸エピネフリル
その他の研究ID番号
- Exparel TKA
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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ケトロラク 30mgの臨床試験
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South China Center For Innovative PharmaceuticalsXiangya Hospital of Central South University完了
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